Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 9:03 AM
Study NCT ID:
NCT00632567
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2008-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EPIC :Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}, {'id': 'D004688', 'term': 'Encopresis'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002585', 'term': 'Cesarean Section'}], 'ancestors': [{'id': 'D036861', 'term': 'Delivery, Obstetric'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 554}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-14', 'studyFirstSubmitDate': '2008-02-28', 'studyFirstSubmitQcDate': '2008-03-07', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Incontinence scores in the two arms after 6/8 weeks and 6 month, transitional anal incontinence after delivery urinary incontinence 6 and 12 month after the delivery, sexual score(IFSI)global morbidity between the two arms after anal endoscopy', 'timeFrame': '6 month and 12 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anal incontinence', 'First delivery was traumatic', 'No anal incontinence'], 'conditions': ['Fecal Incontinence']}, 'descriptionModule': {'briefSummary': 'Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section. So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.', 'detailedDescription': 'Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section.\n\nSo, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective. It seems to be very useful to compare, in randomized controlled study, global morbidity of caesarean section and vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography. In start of study, all women were included, for randomisation ("section cesarean prophylactic" versus "vaginal delivery") if an anal sphincter rupture is diagnosed with anal endosonography before second delivery. . Currently, in case of refusal randomisation, women are proposed to participate to the ancillary study (cohort study).\n\nThe primary endpoint is comparison of median incontinence score of VAISEY in the two arms after 6 months. The secondary endpoints are urinary incontinence, quality of life and global morbidity between the two arms after second delivery. The investigators estimated, needing 123 women in each arm.\n\nHospital investigators are: BICHAT Claude Bernard (Pr LUTON), Armand Trousseau (Pr BENIFLA), Jean VERDIER (Pr CARBILLON), BEAUJON (Pr LUTON), Louis MOURIER (Pr MANDELBROT), Versailles (Dr PANEL). Inclusion will be for 6 years and 9 months. Women will be included during the last trimester and evaluation will be perform on 8 weeks, 6 and 12 month after delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 18 years old\n* Having health insurance\n* Second pregnancy\n* Inclusion in the third trimester\n* First delivery was traumatic\n* No anal incontinence\n* Accept to participate, sign the informed consent\n* Prior medical examination\n\nExclusion Criteria:\n\n* Monitoring impossible\n* Woman who have an anal operation\n* Caesarean section\n* First delivery with anal break stage 4\n* Indication of a scheduled caesarean section not for proctologic reason\n* Patient physically, mentally or legally incompetent to give informed consent'}, 'identificationModule': {'nctId': 'NCT00632567', 'acronym': 'EPIC', 'briefTitle': 'EPIC :Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.', 'orgStudyIdInfo': {'id': 'P060246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'caesarean section', 'interventionNames': ['Procedure: caesarean section']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'vaginal delivery', 'interventionNames': ['Procedure: vaginal delivery']}], 'interventions': [{'name': 'caesarean section', 'type': 'PROCEDURE', 'description': 'caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.', 'armGroupLabels': ['1']}, {'name': 'vaginal delivery', 'type': 'PROCEDURE', 'description': 'vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital BICHAT', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Laurent ABRAMOWITZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}